Pharmaceuticals - Community Register

Community register of medicinal products for human use

AUTHORISED

Product information

Invented name:

IMBRUVICA

Auth. number :

EU/1/14/945

Active substance :

Ibrutinib

Orphan market exclusivity for "Treatment of chronic lymphocytic leukaemia" (based on designation EU/3/12/984) started on 23/10/2014
10 years of market exclusivity
This orphan market exclusivity will expire on 23/10/2024
Orphan market exclusivity for "Treatment of mantle cell lymphoma" (based on designation EU/3/13/1115) started on 23/10/2014
10 years of market exclusivity
This orphan market exclusivity will expire on 23/10/2024
Orphan market exclusivity for "Treatment of lymphoplasmacytic lymphoma" (based on designation EU/3/14/1264) started on 7/07/2015
10 years of market exclusivity
This orphan market exclusivity will expire on 7/07/2025

IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).IMBRUVICA as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.